Dr Cerchione on the FDA Approval of Subcutaneous Isatuximab in Myeloma

The idea of sparing time in [without an] infusion is not only an addition for the patient, but [it] is a way to optimize the time in the hospital.

Claudio Cerchione, MD, PhD, an adjunct professor in the Department of Pharmacy and Biotechnology at the Universita di Bologna and a hematologist at the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS, discussed the significance of the FDA approval of subcutaneous isatuximab-irfc (Sarclisa Escena) delivered via an on-body delivery system (OBDS) for patients with multiple myeloma.

In July 2026, the FDA approved subcutaneous isatuximab, with the agent indicated in newly diagnosed and relapsed/refractory settings. It is specifically approved:

• in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy, including lenalidomide (Revlimid) and a proteasome inhibitor
• in combination with carfilzomib (Kyprolis) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy
• in combination with bortezomib (Velcade), lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant

The subcutaneous approval was supported by data from the noninferiority phase 3 IRAKLIA trial (NCT05405166), in which subcutaneous isatuximab plus pomalidomide and dexamethasone generated an overall response rate ORR of 71.1% (95% CI, 65.2%-76.5%) compared with 70.5% (95% CI, 64.7%-75.9%) for the intravenous (IV) formulation plus pomalidomide/dexamethasone. Furthermore, the subcutaneous/IV geometric mean ratio for observed steady state C_trough prior to treatment on cycle 6, day 1, was 1.53 (90% CI, 1.32-1.78).

The approval of subcutaneous isatuximab administered via an OBDS represents one of the greatest revolutions in the history of multiple myeloma management, given the effectiveness and tolerability that the anti-CD38 antibody adds across both the frontline and relapsed/refractory settings, Cerchione said. Being able to deliver the drug in a safe, fast manner via the OBDS represents a meaningful advance for patient quality of life, on top of the established efficacy and safety of the agent, he explained.

Cerchione added that the OBDS is valued by both patients and hospital staff, as nurses and physicians appreciate a simple tool placed on the skin to perform a safe, fast administration. This approach may increase the number of patients able to receive isatuximab-based treatment, while freeing time to dedicate to other patients and optimizing hospital resources, he concluded.